How to submit a custom-made medical device and patient-matched medical device notification

Name: How to submit a custom-made medical device and patient-matched medical device notification
Creator: Therapeutic Goods Administration
Keywords: custom-made,custom-made-medical-devices,guidances,guide,medical-devices,notification,transition

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Medical Devices Safety, Therapeutic Goods Regulation

Published

December 17, 2023

Last updated

December 17, 2023

Description

This guide will assist you with completing and submitting a Custom-Made Medical Device (CMMD) notification and Patient-Matched Medical Device (PMMD) transition notification.

Organization

Therapeutic Goods Administration (TGA) 🇦🇺

Country / Region

Australia

License

Other (Non-Commercial)

Feedback

Suggest an improvement to this page

3 Main files

How to submit a custom-made medical device and patient-matched medical device notification - step-by-step guide

Updated on December 17, 2023

pdf

URL: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
Permalink: https://data.openrid.co/en/datasets/r/0f8d681a-6112-41be-8e65-20d4bb466064
MIME Type: application/pdf

Created on: December 17, 2023
Modified on: December 17, 2023

How to submit a custom-made medical device and patient-matched medical device notification - step-by-step guide

Updated on December 17, 2023

docx

URL: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.docx
Permalink: https://data.openrid.co/en/datasets/r/fbe058c2-bac3-4cfc-9e87-0d4642123617
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: December 17, 2023
Modified on: December 17, 2023

How to submit a custom-made medical device and patient-matched medical device notification

Updated on December 17, 2023

html

URL: https://www.tga.gov.au/resources/resource/guidance/how-submit-custom-made-medical-device-and-patient-matched-medical-device-notification
Permalink: https://data.openrid.co/en/datasets/r/f03797d6-15bb-4f99-9878-618073358994
MIME Type: text/html

Created on: December 17, 2023
Modified on: December 17, 2023

How to submit a custom-made medical device and patient-matched medical device notification

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